MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED STARDRIVE SCREWDRIVER T40/SELF-RETAINING; SCREWDRIVERS

Catalog Number	03.010.110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: (b)(6).Patient¿s weight is unknown.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that a cannulated stardrive broke during surgery on (b)(6) 2018.The surgeon was trying to take out an end cap when the whole handle broke loose.There was a 30-minute delay in surgery.Procedure completed successfully and patient was in stable condition.Concomitant device: end cap (part # unknown, lot # unknown, quantity 1).This report is for one (1) cannulated stardrive screwdriver t40/self-retaining.(b)(4).
Additional Manufacturer Narrative
The device was received and the product evaluation is in progress.No conclusion can be drawn.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.A device history record review was performed for the subject device: part # 03.010.110.Synthes lot # 5006248.Supplier lot # 5006248.Release to warehouse date: 02 jun 2005.Manufactured at synthes (b)(4).No ncr¿s were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.A product development investigation was performed for the subject device: it was reported that a cannulated stardrive broke during surgery.The surgeon was trying to take out an end cap when the whole handle broke loose.The 03.010.110 cannulated stardrive screwdriver t40/self-retaining is a reusable instrument available for use in several systems and is used for inserting and extracting screws with t40 screw head drive recess geometry.Visual inspection at customer quality (cq) confirmed the reported complaint condition as the device was received in two pieces (shaft separate from handle/dowel pins).However, the returned 12+ year old reusable device has fallen apart, rather than broken.The two opposing dowel pins that secure the cannulated metallic shaft to the phenolic material handle by way of drill/ream/pin operation have migrated outward releasing the cannulated shaft from the handle.Whether this complaint can be replicated at customer quality (cq) via functional test is not applicable for this complaint condition.Review of the device history records showed that there were no issues during the manufacturing of this product that would contribute to this complaint condition the material and relevant material properties were determined to be conforming at the time of manufacture based on review of the dhr.Screwdriver assembly drawings 03_010_110 were reviewed during this investigation.No product design issues or discrepancies were observed.A dimensional inspection was not performed at cq on the 12+ year old device due to the post manufacturing damage.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CANNULATED STARDRIVE SCREWDRIVER T40/SELF-RETAINING
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7247711
• Report Number: 2939274-2018-50536
• Device Sequence Number: 987199
• Product Code: HXX
• UDI-Device Identifier: 10886982067821
• UDI-Public: (01)10886982067821(10)5006248
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.010.110
• Device Lot Number: 5006248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Initial Date Received by Manufacturer: 01/17/2018
• Supplement Date Received by Manufacturer: 02/12/2018; 03/15/2018
• Initial Report FDA Received Date: 02/07/2018
• Supplement Report FDA Received Date: 03/06/2018; 03/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR